Basic Study on Novel Therapeutic Strategy With Bypassing Agent Therapy in Hemophilia A Patients With Inhibitors
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluation of coagulation effects using patients' whole bloods by ROTEM and T-TAS
研究概览
简要总结
Using whole blood samples and plasma samples obtained from some hemophilia A patients with inhibitors, the investigators will perform the coagulation assessment in the co-presence of aPCC and factor VIII by comprehensive coagulation assays and flow chamber analysis under blood flow conditions.
详细描述
Comprehensive coagulation assays using recently popular rotational thromboelastometry (ROTEM), factor Xa/thrombin/plasmin generation test, and coagulation wave analysis and recently developed flow chamber system under blood flow conditions (T-TAS®) will be used. A bypassing agent, aPCC (Feiba®) and recombinant factor VIII (Advate®) will be added ex vivo to whole blood and plasma samples from patients with hemophilia A with inhibitors to compare with the coagulation effects of aPCC in the presence of factor VIII and those of aPCC in its absence under the conditions close to the physiological condition. Furthermore, the difference in the coagulation effects by the difference in inhibitor epitopes will be examined.
研究设计
- 研究类型
- Observational
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with hemophilia A with inhibitors (Inhibitor titer; >0.5 Bethesda U/ml)
- •Patients with agreement consents with the patients signatures
排除标准
- •Patients that do not fill the conditions described above
结局指标
主要结局
Evaluation of coagulation effects using patients' whole bloods by ROTEM and T-TAS
时间窗: up to 15 months
Evaluation of coagulation effects using patients' plasmas by FXa/thrombin/plasmin generation tests and clot waveform analysis
时间窗: up to 10 months
次要结局
未报告次要终点
研究者
Keiji Nogami, MD,PhD
Associate Professor
Nara Medical University